MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA SYRINGE; PISTN SYRINGE

Catalog Number	305283
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the needle failed to retract with a 3 ml bd integra¿ syringe.The following information was provided by the initial reporter: safety integra needle failed to retract into integra syringe as it is designed to do.Left an exposed sharp needle.
Event or Problem Description
It was reported that the needle failed to retract with a 3 ml bd integra¿ syringe.The following information was provided by the initial reporter: safety integra needle failed to retract into integra syringe as it is designed to do.Left an exposed sharp needle.
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

• Brand Name: 3 ML BD INTEGRA SYRINGE
• Common Device Name: PISTN SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8541246
• Report Number: 1213809-2019-00463
• Device Sequence Number: 18924325
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other